Quick links to relevant pages on the TGA website
- The ARTG (Australian Register of Therapeutic Goods). Search the ARTG to find if devices you currently use are already listed: https://www.tga.gov.au/australian-register-therapeutic-goods
- Classification Tool. Use this to help you decide what classification your device falls under: https://www.tga.gov.au/sme-assist/what-classification-my-medical-device#109
- FAQs. These Frequently Asked Questions cover many of the main areas of concern and confusion: https://www.tga.gov.au/regulatory-framework-personalised-medical-devices-frequently-asked-questions
- Glossary of Terms. Search this for definitions of terms e.g. Manufacturer, Supplier, Active medical device: https://www.tga.gov.au/acronyms-glossary
- Inclusion Process. This is a step by step guide for Sponsors applying to include a 'kind of device' in to the ARTG: https://www.tga.gov.au/publication/medical-device-inclusion-process
- Kind of medical device. This page explains the characteristics shared by a 'kind of medical device': https://www.tga.gov.au/kind-medical-device
- The Main TGA Overview Document. Here you can download the TGA Personalised Medical Devices Framework document, the key document to read and refer to through out this process: TGA personalised medical devices framework
- Notification Form. Complete this for each 'kind' of medical device you manufacture/supply to include your device/s in the old system: https://forms.business.gov.au/smartforms/servlet/SmartForm.html?formCode=custom-made-medical-
- An Overview of medical devices regulation: https://www.tga.gov.au/sme-assist/medical-devices-regulation-introduction
- Is your Product a medical device? Work it out by using this tool: https://www.tga.gov.au/my-product-medical-device#1
- Transition Form. Complete this before 25 August to apply to transition your device from custom-made to patient-matched: https://consultations.health.gov.au/tga/accessing-transition-arrangements-patient-matched/
Other
- Information sheet - This is a useful information sheet for members to pass on to your suppliers if they are unaware of the regulatory changes.
- Refinements to the Personalised Medical Device Framework: https://www.tga.gov.au/sites/default/files/refinements-personalised-medical-device-framework_0.pdf
- Dental Sector Working Group's TGA submission
